Makers of Rituxan announce phase III failure as MS treatment

SAN DIEGO The cancer drug Rituxan, marketed by Genentech and Biogen Idec has failed to show that it is an effective treatment for primary-progressive multiple sclerosis. The drug failed during a phase III clinical trial.

Rituxan is approved for use as a treatment for non-Hodgkin’s lymphoma and rheumatoid arthritis.

The trial did not meet its primary endpoint “as measured by the time to confirmed disease progression during the 96-week treatment period,” Hal Barron, Genentech senior vice president, said. However, he added, “there was some evidence of biologic activity.” Genentech and Biogen will continue to review the data.

The phase III randomized, placebo-controlled study was designed to evaluate the efficacy, safety and tolerability of four courses of Rituxan in 439 patients with PPMS. Patients received four treatment courses of Rituxan six months apart or placebo. Serious adverse events were found in 16.4 percent of the Rituxan arm compared with 13.6 percent in the placebo arm.

Contaminated heparin affects 11 countries

WASHINGTON The Food and Drug Administration has announced that the contaminant found in the blood thinner heparin has been discovered in China and has now affected 11 countries including the United States, Canada, Japan, China, Denmark, the Netherlands, Germany, France, Italy, Australia and New Zealand.

Heparin is made from the mucous membranes of the intestines of slaughtered pigs that, in China, are often cooked in unregulated family workshops. The contaminant, identified as oversulfated chondroitin sulfate, a cheaper substance, slipped through the usual testing and was recognized only after more sophisticated tests were used.

But a Chinese official disputed the assertion that the contaminant found in the drug, heparin, caused any deaths and insisted that his country’s inspectors be allowed to inspect the American plant where the finished heparin vials were made. He said any future agreement to allow American inspections of Chinese firms should be mutual. The agency had announced plans to open inspection offices in three Chinese cities, but the agency has yet to get permission from the Chinese government.

Janet Woodcock, director of the FDA’s drug center, said that German regulators uncovered a group of illnesses among dialysis patients who took contaminated heparin. She said Chinese officials had said that heparin produced in their country contained a contaminant, though they say it was not connected to the illnesses.

Bills to require far more aggressive inspections of Chinese products and companies are being proposed by members of Congress. Hearings are scheduled for today in the House and Thursday in the Senate.

Woodcock said the Chinese had agreed to test heparin lots before allowing them to be exported. But Dr. Moheb Nasr, director of the drug agency’s office of new drug quality assessment, said that the Chinese test might not be sensitive enough to identify the contaminant.

Woodcock assured patients, however, that all heparin supplies in the United States had been tested with the most sensitive tests and had been found to be uncontaminated.

Baxter International, which bought heparin ingredients from Changzhou SPL, the Chinese plant identified as the source of contaminated heparin, sold the finished drug in the United States, and said that its tests confirmed that the contaminant could cause illness. It disputed the FDA’s analysis that its product was linked with 81 deaths, saying it had identified only 5 in which its product “may have contributed to the adverse outcome, though there is not yet enough medical data available to draw a firm conclusion that the reaction caused the death.”

Deaths linked to the drug may have been concentrated in the United States because American doctors may be more likely to use large, quickly infused amounts of the drug, said drug officials.

FDA approves Cimzia for Crohn’s disease

WASHINGTON The Food and Drug Administration today approved Cimzia, a new drug by UCB to treat Crohn’s disease.

Crohn’s disease is a chronic, inflammatory bowel disease. It has no cure and its cause is unknown. Crohn’s can cause diarrhea, fever, rectal bleeding, malnutrition, narrowing of the intestinal tract, obstructions, abscesses, cramping, and abdominal pain. It also can lead to abnormal connections (fistulas) leading from the intestine to the skin or internal organs.

Patients treated with Cimzia will receive an injection every two weeks for the first three injections. Once benefit has been established, Cimzia should be given once every four weeks.

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